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EasyGluco MeterManual (Rev.01) (101022)
EasyGluco MeterManual (Rev.01) (101022)
infopia Co., Ltd. 891, Hogye-dong, Dongan-gu, Anyang, Kyunggi, 431-080, Korea www.infopia21.com Obelis S.A. Bd. General Wahis 53, 1030 Brussels, Belgium Tel: +(32) 2. 732.59.54 Fax: +(32) 2.732.60.03 E-Mail : mail@obelis.net Lancing Device : GMMC Room No. 1112, Ace Tower 9th Bldg., 345-30, Kasan-Dong, Kumchon-Ku, Seoul, South Korea Lancet : SAE HAN Medical Corp. 1155-1, Pubgot-Dong, Ilsanseo-Gu, Goyang-City, Gyeonggi-Do, Korea
INFM02A
IMM20-019 Rev.2010-10-01
EasyGluco
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Quick Reference
This is intended only for quick reference. Please read the entire manual before you use the EasyGlucoTM monitoring system.
We understand that self-testing of blood glucose level provides a way to control your diabetes and may give you peace of mind by testing regularly. As a result EasyGlucoTM was developed to provide you with a FAST and Accurate reading with a convenient and simple process. Our goal at EasyGlucoTM is to provide the best quality healthcare products coupled with superior customer service. Always consult with your healthcare professional before making any changes. The EasyGlucoTM System is for in vitro diagnostic use only.
A warranty registration card is included with your system. Please complete the three year warranty card and send it to us. This will ensure that you receive any new information about your EasyGlucoTM System. If you have any questions, please contact your local representative.
Apply sample until confirmation window is completely filled before the Meter begins to countdown. If the confirmation window does not fill completely, do not add more blood to the test strip. Immediately discard the test strip and then retest.
EasyGlucoTM
EasyGlucoTM
Important Information
Before using the EasyGlucoTM Blood Glucose Monitoring System, read all of the operating instructions in this Operation Manual to practice for safe and accurate testing. The EasyGlucoTM Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use only). EasyGlucoTM was designed only to test blood glucose (sugar) levels and can only be used with fresh capillary whole blood samples. It should not be used for the diagnosis of diabetes or for the testing of newborns (neonates). Do not use the EasyGlucoTM System for any purpose other than for blood glucose testing. Consult with your physician or diabetes healthcare professional for the proper use of this meter and daily management of your diabetes. Please pay close attention when handling blood. Improper procedures may cause serious hazards to your health.
TABLE OF CONTENTS
Learning The System
EasyGlucoTM Blood Glucose Monitoring System KIT Contents EasyGlucoTM Blood Glucose Meter EasyGlucoTM Blood Glucose Meter Display EasyGlucoTM Blood Glucose Test Strip Important EasyGlucoTM Test Strip Information Checking the Meter with the Check Strip Coding The Meter Checking the System with the EasyGlucoTM Control Solution Setting The Meter Collecting a Drop of Blood Testing Your Blood Reviewing Your Results Maintaining the EasyGlucoTM Meter Battery 1 2 3 4 5 6 7 8~11 12~13 14~15 16~19 20~21 22 23 24~27 28 29 30
Before Testing
Testing Your Blood Reviewing Your Results Caring for Your Meter Troubleshooting Specifications Warranty Note
If you have any questions about the use of the EasyGlucoTM product, please contact your local representative.
EasyGlucoTM
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Check your EasyGlucoTM system to make sure that it is unopened prior to use and that it contains all of the complete parts shown above. If either of these conditions are not met, please return your system to the place of purchase or contact your nearest Infopia representative.
TEST PORT : Insert the EasyGlucoTM Test Strip here. DISPLAY : Symbols, simple messages, and test results appear here. MEM BUTTON : Use for reviewing past records and setting for Time,Date, Month and Year(Refer to pages 12, 13, 20 and 21). SET BUTTON : Use for recalling past results, and setting Time, Date, Month, Year mode and the code number(Refer to pages 7, 12, 13, 20 and 21).
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Blood is applied to the Top Edge of the EasyGluco TM Test Strip and is automatically drawn into the channel where the reaction takes place Check here to confirm if enough blood have been applied
Low battery warning Message area reads the results and messages Indication for deleting records
CONTACT BAR Insert this end into the Meter. Push it all the way in until it will go no further.
front Month
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Day
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The Check Strip automatically checks the Meter when inserted into the Test Port. A V symbol will appear on the LCD screen, indicating that the Check has been made. Please Insert the Check Strip with<<<facing up into the test port of the Meter. If the value displayed is ranged between 107127, the Meter is good to use. If the value displayed does not meet the proper range, reinsert the calibration key 2 or 3 more times. If it s still does not meet the proper range, please contact your local representative. Please note that the Check Strip does not check the POWERONstatus of the Meter.
Avoid getting dirt, food, and water on the test strip. Do not handle test strips with wet hands. Do not use test strips after the expiration date printed on the package or vial since it may cause inaccurate results. Do not bend, cut, or alter an EasyGlucoTM Test Strip. EasyGluco Test Strips are for single use only. Do NOT re-use.
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STEP 1
Insert the EasyGlucoTM Test Strip to turn on the Meter. Push it all the way in until it will go no further. Avoid bending the test strip. The code number will appear on the LCD window for 3 seconds. Compare the code number (example: C17) on the Meter s LCD window with the code number on the test strip vial. If these two code number matches, you can start testing. If any error messages appear any time, refer to the Troubleshooting section of the booklet for more information, see page 24.
STEP 2
If the two code numbers do NOT match, you must code the meter according to the test strip vial code number before the LCD display ends. Press the SET button to select the correct code. The number increases by one digit every time you press the SET button. To move more quickly, press and hold the SET button. After selecting the correct code number, it will appear solid for a second. Then the Strip-Shape symbol on the LCD will starts blinking, indicating that the EasyGlucoTM System is ready for testing.
Practice the test procedure. Make sure your meter and test strips are working together properly. Ensure you are performing the test correctly. Before you use the EasyGlucoTM Meter to test your blood for the first time, practice the procedure using the control solution. When you can do three tests in a row that are within the expected range, you are ready to test your blood. Do a control solution test: When a new vial of test strips are opened. Any suspicion that the meter or test strips are not working properly. When your blood glucose test results are not consistent with your symptoms, or if you think they are not accurate. If you drop the meter. Use routinely to obtain accurate results. The control solution test is similar to a blood test except that you use the EasyGlucoTM Control Solution instead of a drop of blood.
CAUTION : If you do not adjust and match the code numbers, you may
receive inaccurate test results.
Important: Each time you test, be sure to check that the code number on the meter display matches the code number on the Test Strip vial.
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CAUTION : The control solution range printed on the Test Strip vial is for the EasyGlucoTM Control Solution only.
It is used to test the meter and test strip performance. It is not a recommended range for your blood glucose level.
STEP 2: Apply Control Solution Shake the control solution vial well. Remove the cap. Invert the bottle and discard the first drop of the control solution. If large bubbles are present at the tip of the vial, wipe the bubbles off with a clean tissue before applying the drop of control solution to the test spot. Do not drop bubbles on the test strip. Apply an entire drop of the control solution onto the test spot at once by gently squeezing the vial to form a small drop. Take the meter with the test strip inserted and touch the end of the test strip to the hanging drop (picture 2). Be sure to hold the test strip to the drop until you hear a beep sound.
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Turn on the meter by pressing the SET button for 3 seconds. This will initiate the Set the Metermode.
How to Calculate Your Average Blood Glucose Level
If the control solution test results fall outside the range, repeat the test. Out of range results may be caused by one or more of the following: Error in performing the test. Failure to shake the control solution vial well enough (must shake vigorously). Failure to discard the first drop of control solution. Expired or contaminated control solution. Test Strip deterioration. Meter malfunction (Use the Check Strip in your EasyGlucoTM kit to check the meter). Control solution that is too warm or cool.
Move to next
The setting mode begins with setting the number of days of which you would like to receive an average calculation of your glucose level. The LCD window will be flashing the most recent number of days that was selected. The number of days can range from 7 days to 90 days. To increase the number of days, press the SET button; holding the SET button down will increase the value at a quicker rate. With the correct number of days displayed, press the MEM button. This will set the number of days that you would like to receive your average blood glucose calculation. (By pressing the MEM button it saves your settings as well as moves you to your next item to set).
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Note : For even finer adjustment, the arrow may be placed between any two numbers.
CAUTION : Without setting the date properly, the average glucose level and the results in memory will not show proper values but instead an error message will be displayed. It is highly recommended to set the meter before use and when new batteries are installed. You cannot test your blood glucose while in the setting mode.
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CAUTION : Use a new, sterile lancet every time you test. Do not use lancet if protective cover has been removed or damaged. Never share a lancet with anyone.
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4. Hold the tip in one hand and pull on the sliding barrel with other hand. Pull the ends apart and you will feel a click. This indicates that the lancing device is in a locked position ready for lancing.
5. Release the sleeve. It will automatically contract and move back to its original position near the trigger hub.
6. Place the lancing device against the tip of the finger. Press the trigger button. Your blood sample should now be ready to be applied on the test strip. Lift the lancing device out and away.
Maintaining your Lancing Device - Unscrew the lancing device tip. Carefully stick the protective disk cover back on the used lancet. - Grip the holder firmly and pull the lancet safely out of holder. Screw the tip back on the lancing device. - Discard the used lancet to a proper place. Clean the lancing device if blood or stain remains. CAUTION : Use a new sterile lancet every time you test. Do not use lancet if protective cover has been removed or damaged. Never share a lancet with anyone.
WARNING :
The Lancing Device and Sterile Lancets should NOT be shared with others. It is only for your own personal use. Always use a new, sterile lancet. Lancets are for single use only. Avoid getting hand lotion, oils, dirt, or debris in or on the Lancets and the Lancing Device. Dry your hands completely before testing.
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STEP 1.
Firmly insert the EasyGlucoTM Test Strip into the EasyGlucoTM Meter test port. With the Arrow sidefacing up and in the direction of the arrow, insert it into the test port of the Meter firmly. The meter will automatically turn on and display the code number. Make sure the code number on display matches the code number on the test strip vial. If the code number does not match, code the meter correctly. See Coding The Meter page. Note: Inserting the test strip in the wrong direction will turn the meter on or but the test will not be done.
poorly filled
incorrect
CAUTION :
If you did not confirm the code in 3 seconds, pull the electrode out of the port, and re-start the procedure from the beginning. If the codes on the LCD display window and on the test strip vial do not match, do the Coding The Meter procedure for accurate result.
CAUTION : If you do not conduct the test after 3 minutes, the meter will automatically power off to save battery life.
the test procedure should start again from the beginning. In this case,
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The meter enters Reviewing Your Results mode by pressing the MEM button.
TM logbook. This will help you reference your blood glucose levels historically. When the testing is complete, discard the used test strip and lancet to a proper place. Make sure to retain all necessary EasyGlucoTM items in the leather case for your next test. Clean the meter if necessary according toMaintaining the EasyGlucoTM Meter .
The first display shows the current date and time, then the average glucose level calculation over the period that was already pre-set.
CAUTION : If you receive any error messages please refer to theTroubleshootingsection of this Manual.
If no data was saved, the meter will display X and powers off automatically after 3 seconds.
If no data was saved for the pre-set days for the average glucose calculation, the meter will display a zero and display each value of the past results
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To delete test results individually, press the SET button for 5 seconds until you hear 3 beep sounds and the LCD display shows the test result and time you want to delete. To delete all test results in memory, press the SET button until you hear a beep sound and at the same time press the MEM button. Please be careful, once the results is deleted it cannot be restored.
CAUTION : If you do not set the Meter properly, the average glucose level for the days you set and the results in memory will not
show proper value but indicate an error message. Improper settings will cause an Er3 message to appear on the LCD window. Refer to Setting the Meter.
7. Do not subjet the meter and the strips to exesive heat. 8. Use your EasyGlucoTM Meter according to the instuctions in the manual.
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Battery
Your EasyGlucoTM Meter comes with two 3.0V (CR2032 or equivalent) lithium batteries. The batteries will provide you with enough power to perform about 5,000 tests. When replacing the battery, 3.0V (CR2032 or equivalent) lithium battery can only be used. The meter will alert you when the power is getting low by displaying this symbol (symbol of battery and its low sign) or when the meter does not power on by any means. To replace the battery, make sure that the Meter is in the OFF position when changing the batteries. When changing the batteries, be careful of the polarity of the batteries which is printed in the battery deck of the meter. After changing the batteries,Setting The Meter , MUST be done again for secure and accurate test results.
Troubleshooting
Problems that you may encounter : Following may help you to identify certain problems but may not represent all the problem that occurs. Please avoid any IMPROPER use of the meter and the parts associated with the EasyGlucoTM System.
MESSAGE
CAUSED BY
Problem with the Meter
WHAT TO DO
If problem persist,contact your local representative.
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Troubleshooting
MESSAGE CAUSED BY
No saved data
Troubleshooting
WHAT TO DO MESSAGE CAUSED BY
The test result is lower than 10mg/dL (0.6mmol/L)
WHAT TO DO
If you believe that your result is incorrect, recheck the meter by using the EasyGlucoTM Control Solution. With normal result, re-test with blood samples two or three times.LOresults indicate severe hypoglycemia (low blood glucose). If theLOmessage persists, please contact your physician or diabetes healthcare professional.
Place the meter at the operating temperature range for more than 10 minutes, and re-test.
If you believe that your result is incorrect, recheck the meter by using the EasyGlucoTM Control Solution. With normal result, re-test with blood samples two or three times.HIresults indicate severe hyperglycemia (high blood glucose). If theHImessage persists, please seek medical attention immediately.
Place the meter at the operating temperature range for more than 10 minutes, and re-test.
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Troubleshooting
Please refer to the table below to identify problems that persist with no messages appearing.
Specifications
WHAT TO DO
Change the batteries and if the problem persists, contact your local representative.
PROBLEM
The meter does not power on
CAUSED BY
Batteries are dead or there is a problem with the meter.
Specifications
IGM-0002A 0.6~33.3 mmol/L (10~600 mg/dL) 9 sec 200 test results 50-104F(10-40C ) 10 ~ 90% Capillary Whole Blood Plasma-Equivalent
Hematocrit Sample Volume Display Type Size (D X W X H) Weight Power Source Battery Life Glucose Unit
30 ~ 55% Minimum 1.5 LCD 22.8 X 54.5 X 91 (mm) 55g (including batteries) 3V Li Battery (CR2032) X 2 running 5000 tests Either mmol/L or mg/dL
Apply a sufficient amount of the blood sample to a new test strip and re-test. Re-test with a new strip.
There may be a problem with the test strip The codes of the meter and of the test strip vial do not match
Calibration
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Warranty
Three-Year Warranty If, at any time during the first three years after purchase, the meter does not work for any reason with the exception of obvious abuse, misuse, or disastrous damage, Infopia will replace your EasyGlucoTM Meter or equivalence free of charge. The Warranty Policy of Infopia only applies to the original purchaser of the Meter and will not include the batteries supplied with the Meter set. Please fill in the warranty card attached to the set. Mail or fax it back to us. The EasyGlucoTM Meter has a full three-year warranty from the original date of your purchase. For your convenience, please include your date and place of purchase.
Note
Please refer to the table below to identify symbol Serial number Consult operating instructions
This product fulfills the requirements of Directive 98/79/EC on invitro diagnostic medical devices.
Used by
Manufactuing date Caution, consuit accompanying documents Keep away from sunlight In vitro diagnostic device Self-testing Used Batch code Waste electrical and electorinic equipment Catalogue number Manufacturer Store at
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Memo
Memo